N9 Science Events: November 10th, 2013.

A court's eye view of patentability

Helen Gavaghan reports a seminar on personalised medicine, biotechnology and the patent system, focussed on a presentation by Graham Dutfield on 6th November at The University of Leeds.

Citing Nature Biotechnology from 2008¹ Graham Dutfield² last Wednesday opened a seminar at the University of Leeds on the intellectual property issues relevant to biotechnology and personalised medicine by saying that personalised medicine is becoming viable. Professor Dutfield was speaking to attendees drawn from across the University, who were invited by the stratified medicine hub. He is chair of international governance at the University of Leeds school of law.

In his talk Professor Dutfield illustrated how legal decisions are seeking to define where nature ends and artifice begins, and where those decisions are de facto laying down lines in the sand between State control and corporate responsibility via regulatory control or patentability.

For example, he described a 2008 case in which the British, French and German Courts reached differing conclusions about the patentability of new use for an existing drug for a new therapy. The British eventually upheld the patent, covering use of Finasteride for male pattern baldness at a dosage of 0.05 mg to 1 mg, compared with a dose of 5 mg for treatment of enlarged prostate, for which the drug was initially approved. The British court said the new use was non obvious, because it was thought there was a low chance of success, and novel, because no-one had suggested such a thing. The German Courts invalidated the patent claims, but accepted the dosage regimes in principle. The French revoked the patent.

Thus the different national decisions in the case of Finasteride set novelty and non obviousness in conflict with predictability in biology. By predictability here I mean predictability of the biology, not of efficacy and safety within a patient group.

Professor Dutfield told his audience, "Statutory law and precedent provide formal doctrinal basis for court decision-making in common law jurisdictions". All his examples of disputes were drawn from the pharmaceutical industry, and selected to exemplify current areas of patent conflict of most relevance to personalised medicine.

Intent and meaning of law, and justice in a specific case drive judicial decision making, he said. Judges draw sometimes on reasoning by analogy when considering unfamiliar subject matter, the analogy not necessarily conceived consciously.

The areas of conflict he identified were:

Incremental product inventions

Methods and use claims for optimising or personalising dosage regimes

Use of old drugs for newly defined patient groups

In the case of AMP v USPTO isolated strands of DNA containing introns were eventually (June 2013) deemed unpatentable, because the genes exist in nature. By contrast complementary DNA [cDNA] created subsequently by technical intervention was held patentable. The reasoning being that the intervention had created something distinct from nature, even though cDNA in the normal course of events is part of the natural process of cell division. The US Supreme Court settled the case in June 2013.

Commenting on this article prepublication Professor Dutfield said, "I think it is worthwhile to state that in Europe isolated DNA is still patentable."

Another court, this time the Indian Supreme Court, has also determined that a new form of a drug, such as a β-crystalline form, is not patentable if it does not significantly enhance the efficacy of the original.

In the case of fulvestrant in the treatment of women with resistant breast cancer the issue was the technical aspect of the drug which made is suitable for women who had undergone a particular treatment regime which had failed. The claim was upheld.

The world in which these judicial decisions were made is one, said Professor Dutfield, of increasingly intense regulatory scrutiny, ever increasing biological complexity, disease complexity and undruggability, neglected diseases and the end of life time of many patents, the so-called patent cliff of significance to corporate finances.

It is against this background, said Professor Dutfield, that the new drug development paradigm of open innovation is mooted. The idea being that firms use external flows of information, as well as internally generated IP, and use external and internal paths to market.

Discussion subsequent to Professor Dutfield's presentation centred in large part around the relationships among medicine, intellectual property, regulatory regimes and biology.

1. Allison M. "Is personalised medicine finally arriving?" Nature Biotechnology, 8th July, 2008.
2. See also: http://www.law.leeds.ac.uk/about/staff/dutfield/

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